A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

  • Clinical Trial Information

    Trial Contact: Ribacchi, Stephanie; Durand, Jennifer; Casillas, Bridey L

  • IRB No: Pro00069690

    Protocol Abbrev: NSABP-B-62-AZ-CAMBRIA-1

    Principal Investigator: Nikita Chandrakant Shah, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: D8531C00002

    Treatment: Arm A: Continue the standard ET of investigator’s choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] with or without luteinizing hormone-releasing hormone [LHRH] agonist[s] or tamoxifen, standard dose per investigator or per instructions in the patient dosing card, once daily) Arm B: Camizestrant (75 mg, once daily) with or without LHRH agonist(s).

    Therapies Involved: Medication ID: NCT05774951

  • Objective

    To demonstrate superiority of extended therapy with camizestrant as compared to standard ET by assessment of invasive breast cancer-free survival (IBCFS).

  • Key Eligibility

    Inclusion Criteria:
    •   Women and Men, ≥18 years at the time of screening (or per national guidelines)
    •   Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
    •   Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumor(s), with or without (neo)adjuvant chemotherapy.
    •   Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET.
    •   Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed.
    •   Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
    •   Adequate organ and marrow function